Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
|
Event Date 12/12/2022 |
Event Type
Injury
|
Event Description
|
It was reported by the patient¿s legal counsel that the patient underwent a right hip arthroplasty.Subsequently, the patient underwent a revision procedure eleven years post implantation due to unknown reasons.Attempts have been made and it was reported that no additional information is available.
|
|
Manufacturer Narrative
|
(b)(4).D10: unknown taper unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02380.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04) - head.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised eleven (11) years post implantation due to metal related pathology, elevated metal ions, pseudotumor, corrosion of trunnion and tissue damage.Liner and head revised and exchanged.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and/or corrected information.D10: 00771100900 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset 61559510.00875705202 52mm o.D.Size ii porous uncemented with multi-holes shell use with ii liners 61629434.00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 61738443.00625006535 bone screw self-tapping 6.5 mm dia.35 mm length 61738504.00875201032 32mm i.D.Size ii elevated rim liner use with 52mm o.D.Size ii shell 61477097.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04) - head.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed, and the patient was revised ten years post implantation due to elevated metal ions and a pseudotumor.During the revision, tissue damage and bone loss to the femur was identified.Corrosion was noted to the trunnion.The liner and head were explanted and replaced with zb products.This complaint was confirmed based on the provided medical records.Root cause unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and/or corrected information.
|
|
Search Alerts/Recalls
|